Kornimate/medical-research-clean huggingface dataset:
student outcomes of integrative mental health services

Conditions: Anxiety; Depression; Trauma; Behavior Problems

Summary: the study will compare the impact of child steps (see weisz et al., 2012) versus usual school-based therapy on students' mental health and school-related outcomes, and test whether changes in school outcomes are mediated by changes in student mental health.

this project will implement and evaluate the child steps (see weisz et al., 2012) treatment approach through a randomized controlled trial (rct) at 27 k-8 public schools. the steps model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists, to guide their selection and sequencing of the steps modules. the project will include an evaluation of the effectiveness of steps compared to "treatment as usual" (known as usual care or uc) on students' mental health and school-related outcomes, and an analysis of whether changes in school outcomes are mediated by changes in student mental health.

Eligibility criteria:
inclusion criteria: 1. enrolled in grades 2-7 2. have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress 3. clinically elevated problem levels on the internalizing, externalizing, anxious-depressed, withdrawn-depressed, aggressive behavior, or rule-breaking behavior scales of the child behavior checklist or youth self-report or on the ucla post-traumatic stress disorder reaction index exclusion criteria: 1. mental retardation 2. pervasive developmental disorder 3. eating disorders 4. children for whom attention problems or hyperactivity are the primary referral concern 5. active psychosis and/or a suicide attempt in the previous year

Keywords: anxiety depression trauma behavior problems evidence-based treatments manualized treatments cognitive-behavioral therapy youth mental health
captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms

Conditions: Aneurysm

Summary: thoracic aortic aneurysms (taa) are considered "silent killers" because they scarcely display any symptomatology, but are correlated with significant mortality and morbidity. current guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker (bb) therapy. no therapy, however, is effective at limiting aneurysm expansion and preventing rupture, even in large trials. taa has emerged as an inflammation-mediated disorder. angiotensin-converting enzyme inhibitors (aceis) can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm. the study will be a randomized, double-blind trial. patients will be randomized into one of two parallel arms, receiving captopril or atenolol. the doses of captopril and atenolol will be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and bp estimates. the sample size will be set at 424 subjects (212 per group). the primary end-point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on mri of the aorta after 36 months of therapy with captopril vs. atenolol. bbs have not been precisely found to decrease aneurysm growth rates. aceis could lead to the prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory properties. the results of this trial will clarify that aceis are superior to bb therapy in reducing the growth rate of taas, the rate of change in aortic insufficiency, the time to aortic rupture or dissection, the need for aortic surgery or intervention, and death.


Eligibility criteria:
inclusion criteria: all adult men or women, aged at least 70 years, with taa 3.0-5.5 cm in diameter measurements according to magnetic resonance imaging (mri) of the aorta and with a systolic bp \< 150 mmhg will be eligible for inclusion in the study. exclusion criteria: patients already receiving an acei or bb daily, patients with known renal artery stenosis (\> 50%), patients incapable of providing informed consent, history of aortic dissection, angioedema or any intolerance to aceis or bbs, asthma, pregnancy, frailty, respiratory failure, and renal failure.
full length versus proximal renal arteries ablation

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. this study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.

after baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. this study is going to recruit 40 patients (group 1 vs group 2 = 1:1) with a follow-up duration of one year. group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. rdn was performed with saline irrigated catheter. office and ambulatory blood pressure was measured.

Eligibility criteria:
inclusion criteria: * office systolic blood pressure of 160 mm hg or more, * patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment. * despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications; * ≥ 18 years old,; * did not have any known secondary cause of hypertension; * had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more. exclusion criteria: * patients with type 1 diabetes, * implanted pacemakers or implantable cardioverter defibrillators; * pregnant women; * haemodynamically significant valvular disease; * patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
action observation therapy on balance in children with down syndrome

Conditions: Down Syndrome

Summary: down syndrome is a condition in which a child is born with an extra copy of their 21st chromosome hence its other name is trisomy 21. the hallmarks of down syndrome are mental retardation, hypotonia and characteristic phenotype features. balance is one of the major issue. action observation therapy focus on the concept of balance improvement.

the study will be randomized controlled trail used to evaluate the effectiveness of action observation therapy on balance in children with down syndrome. subjects with down syndrome meeting the inclusion exclusion criteria will be divided into two groups using non-probability sampling technique. assessment will be done using pediatric balance scale(pbs) and timed up and go test(tug) . control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy + action observation therapy.

Eligibility criteria:
inclusion criteria: * children with age group of 6-12 * both male and female * body mass index (bmi) within normal range (57.1%) * absence of any psychiatric and physical illness at the time of participation exclusion criteria: * uncontrolled seizures * any kind of orthopedic condition * registered visually impaired * severe atlanto axial instability * unable or unwilling to understand and attempt the task

Keywords: action observation balance down syndrome rehabilitation
near-infrared image guided surgery in pancreatic adenocarcinoma

Conditions: Pancreatic Cancer; Pancreatic Adenocarcinoma

Summary: there is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. the biomarker vascular endothelial growth factor (vegf-a) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. vegf-a can be targeted by the monoclonal antibody bevacizumab. monoclonal antibodies can be labeled by the near-infrared (nir) fluorescent dye irdye800cw (800cw). the investigators hypothesize that bevacizumab-800cw accumulates in vegf expressing cancer, enabling pancreatic cancer visualization using a nir intraoperative camera system. in this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800cw (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients with clinical suspicion of pancreatic head cancer who are scheduled to undergo surgical intervention with curative intent * world health organization (who) performance score 0-2. * signed written informed consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent. * other invasive malignancy * pregnant or lactating women. documentation of a negative pregnancy test must be available for woman of childbearing potential. woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause. * prior neo-adjuvant chemo- of radiotherapy * history of infusion reactions to bevacizumab or other monoclonal antibody therapies. * inadequately controlled hypertension with or without current antihypertensive medications * within 6 months prior to inclusion: myocardial infarction, transient ischemic attack, cerebral vascular accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris. * anticoagulant therapy with vitamine k antagonists * patients receiving class 1a (quinidine, procainamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents * evidence of qtc (corrected qt interval) prolongation on pretreatment ecg (greater than 44ms in males of greater than 450ms in females) * magnesium, potassium and calcium below the lower limit of normal range.
lumbar infiltration with steroids - effects on pain reduction

Conditions: Low Back Pain

Summary: questionnaire for patients who got a lumbar infiltration in our clinic. the patients will have to answer questions concerning their pain. (the lumbar infiltration itself is not part of this study)

questionnaire are given to patients who got a lumbar infiltration in our clinic of rheumatology. these patients will have to answer questions concerning their pain. (the lumbar infiltration itself is not part of this study).

Eligibility criteria:
inclusion criteria: * patients who got a lumbar infiltration in our clinic. exclusion criteria: * infiltration of thoracal or cervical spine.
efficacy and safety of traditional chinese medicine (tcm) comprehensive therapy in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is prospective randomized, controlled study to evaluate the efficacy and safety of qingre huoxue comprehensive therapy in treating of patients with early rheumatoid arthritis (ra). the major outcome index is the change from baseline to week 24 in disease activity score (das28), and minor outcome indexes include american college of rheumatology (acr)20/50/70, pro score, sharp score and omeract ramris score. the adverse events at any time were recorded to evaluate the safety.

three arms were included in this study, and treatment with mtx and hcq is defined as active comparator. treatment of tcm，including qingre huoxue granule, qingre huoxue external preparation, mtx placebo and hcq placebo, is defined as one experimental arm. treatment of integrative medicine，including qingre huoxue granule, qingre huoxue external preparation, mtx and hcq, is defined as another experimental arm.

Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis as determined by the 1987 acr classification criteria. * diagnosed with tcm dampness heat and blood stasis syndrome * the course of ra is not more than 5 years. * swollen joint (sjc)≥2 and tender joint count(tjc)≥3. * erythrocyte sedimentation rate（esr）≥20 mm/hr * patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study. * age 18-65 years with informed consent exclusion criteria: * patients with skin burst or allergies. * patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath * active or chronic infection, including hiv, hepatitis c virus, hepatitis b virus, tuberculosis * previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (dmard) in 3 months. * previous treated with mtx or hcq * patients with retinopathy.
phase ii study on gusperimus in patients with refractory wegener's granulomatosis

Conditions: Wegener's Granulomatosis

Summary: wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. conventional therapy of wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. the efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. a prospective, international, nulti-centre, single limb, open label study. entry required active wegener's granulomatosis with a birmingham vasculitis activity score (bvas) \>=4 and previous therapy with cyclophosphamide or methotrexate. immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. cycles were stopped early for white blood count \< 4,000/mm3. the primary endpoint was complete remission (bvas=0 for at least 2 months) or partial remission (bvas\<50% of entry score). after the sixth cycle azathioprine was commenced and follow-up continued for a further six months.


Eligibility criteria:
inclusion criteria: * documented diagnosis of wg according to american college of rheumatology (acr) and chapel hill consensus conference (chcc) definition * bvas \>= 4 * total disease duration \>= 3 months treated with cyc or \>= 6 months with mtx * age 18 - 80 * wbc \>= 4,000/mm3, haemoglobin \>= 8g/dl, neutrophils \>= 2,500/mm3, platelets \>= 100,000/mm3 * alt, bilirubin and alkaline phosphatase levels within 2x the upper limits of normal * documented to be non-pregnant by serum/urine pregnancy test * willing to participate in this study * provide signed informed consent * able and prepared to self-administer the study drug or have a close friend/relative able to do this exclusion criteria: * participation in another clinical research study * pregnant or nursing mothers and women of childbearing age not using appropriate contraception * clear evidence of active disease due to bacteria/viral infection * patient has an unacceptable risk for participation in a study of immunosuppressive therapy * history of substance abuse or psychotic disorders * previous treatment with gusperimus

Keywords: wegener granulomatosis vasculitis gusperimus immunosuppression
process and outcome evaluation of different psychotherapies

Conditions: Mental Illness; Psychiatric Disorder; Mental Disorder

Summary: in this study, adult patients and therapists at the outpatient clinic for psychotherapy of the paris lodron university salzburg will complete questionnaires throughout the course of psychotherapy in order to evaluate the course and outcome of psychotherapy.


Eligibility criteria:
inclusion criteria: * patients: indication for psychotherapy, adult patients capable of giving consent, with sufficient knowledge of german to complete the questionnaires, signed treatment contract and declaration of consent * psychotherapists: officially registered psychotherapists and psychotherapists in training under supervision (in austria), signed work contract and declaration of consent

Keywords: psychotherapy
treatment of early childhood depression

Conditions: Depression

Summary: depression often occurs in early childhood. moreover, later depression is frequently preceded by early childhood depression (ecd). however, at present, there is a lack of evidence-based tratestments (ebts) for ecd, posing a core research desideratum highlighted by both the american and german practice parameters for ecd. the current study seeks to redress this research gap, by evaluating the feasibility and dose-dependent effectiveness of manualized short-term psychoanalytic child psychotherapy (pact) compared to waitlist in a randomized controlled trial (rct) among clinically referred 3 to 8-year-olds with ecd. comprising 20-25 sessions in alternating settings (child-only, caregiver(s)-child, caregiver(s)-only), pact focuses on internal conflicts and representations underlying depressive disorders. pact targets the child-therapist relationship, using interpretative, play and mentalization-based techniques, aiming to elicit the interpersonal meaning of the child's symptoms within the child-caregiver relationship(s).

for this trial, 62 clinically referred children meeting criteria for dsm-5 depressive disorders, will be randomized randomized to pact (n=31) or waitlist (n=31). the overarching aim is to engender reduction in depressive symptoms and diagnoses following pact vs. waitlist in order to determine effect sizes which can be used in power calculations for future large-scale clinical trials. moreover, effects of pact will also be examined at mid-treatment to provide a first insight into the necesary therapeutic dose. moreover, the trial will also be used as a first opportunity to examine feasibility of pact in young children, treatment integrity, as well as treatment acceptability.

Eligibility criteria:
inclusion criteria: * age 3 to 8 years * dsm-5 depressive disorder (major depression, dysthymia, depression nos), adapted for young children according to the aacap criteria * written informed consent of patient's parents or guardian * informed verbal assent from children (age \>= 6 years) exclusion criteria: * iq \< 70 * autism spectrum or schizophrenia spectrum disorder in the child * insufficient german language skills to participate in treatment (child or caregiver) * ongoing litigation regarding child custody * concurrent intensive psychotherapy * participation in other interventional trials * suspected lack of compliance

Keywords: early childhood depression
progress adult study

Conditions: HIV; Depression

Summary: the purpose of this study is to study the hiv disease progression in hiv-infected thai adult.

this is a multicenter, observational prospective cohort study. all hiv-infected patients from bamrasnaradura institute, sanpatong hospital and hiv-nat, thai red cross aids research centre, are followed to assess hiv disease progression.

Eligibility criteria:
inclusion criteria: 1. there is evidence that hiv infection true (blood positive results by elisa (elisa) has been confirmed or detected evidence co-infection. hiv in the body by pcr, hiv-rna pcr).currently on pi regimens 2. signed consent form 3. age\> 18 years exclusion criteria: 1. patients who came for treatment in a department other than out patient, such as inpatient or emergency room. 2. patients are not willing to receive treatment on a regular basis in all 3 hospitals as patients normally receive treatment at other hospitals on a regular basis. however, due to urgent events. need to receive treatment in hospital and three of. 3. patients who have been diagnosed by doctors as a psychological disorder that can not store the data. 4. patients who have been diagnosed by a medical condition that alcoholism

Keywords: hiv related adverse events immunological failure virological failure quality of life depression genotypic resistance
comparative pharmacokinetic, pharmacodynamic, safety and efficacy study of three anti-cd20 monoclonal antibodies in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of drl_ri or one of two sources of rituximab (rituxan® or mabthera®). patients will also be monitored for safety, b cell depletion and recovery, and for the development of immune responses to the administered study drugs


Eligibility criteria:
inclusion criteria: 1. male or female patients, 18 to 65 years of age 2. diagnosis of ra, according to acr criteria (1987), of at least 6 months duration 3. at randomization, tender joint count ≥ 6 and swollen joint count ≥ 6 4. evidence of at least moderate disease activity 5. patients receiving oral or parenteral mtx with a dose of 15 to 25 mg per week when given alone or 10 to 25 mg per week in combination with additional non-biologic dmard(s) for at least 6 months and on stable dose for at least 3 months 6. patients must be on a stable dose of folic acid or equivalent (≥5 mg per week) 7. chest x-ray not suggestive of any lung infections including pulmonary tuberculosis (tb) 8. contraception required per protocol exclusion criteria: 1. prior therapy with * rituximab, abatacept, tocilizumab, anakinra or an agent/antibody targeting cd20, cd19 or b cells * tumor necrosis factor (tnf) alfa antagonists or other biologic dmards other prior or concurrent therapies may also be excluded 2. any clinically relevant abnormality detected on screening history, physical examination, clinical laboratory, chest x-ray, or electrocardiogram (ecg), other than values consistent with ra 3. evidence of active, suspected or inadequately treated tb 4. positive serological test for hepatitis c virus antibodies, hepatitis b surface antigen, hepatitis b core antibody, or human immunodeficiency virus 5. history of cardiovascular disease, history of stroke, or uncontrolled hypertension 6. history of lymphoproliferative disease or organ allograft 7. history of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for \>5 years) 8. history of allergy (medication history) to any of the compounds used in the study 9. pregnant or lactating women or women planning to become pregnant during the study

Keywords: rheumatoid arthritis rituximab pharmacokinetics